EP3158960B1 - Electrode with a throttle for preventing burns induced by hf leak currents - Google Patents
Electrode with a throttle for preventing burns induced by hf leak currents Download PDFInfo
- Publication number
- EP3158960B1 EP3158960B1 EP15003024.5A EP15003024A EP3158960B1 EP 3158960 B1 EP3158960 B1 EP 3158960B1 EP 15003024 A EP15003024 A EP 15003024A EP 3158960 B1 EP3158960 B1 EP 3158960B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- electrode
- handpiece
- body contact
- contact element
- throttle
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Links
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
- A61B5/276—Protection against electrode failure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/30—Input circuits therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
- A61B5/6848—Needles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2505/00—Evaluating, monitoring or diagnosing in the context of a particular type of medical care
- A61B2505/05—Surgical care
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/02—Details of sensors specially adapted for in-vivo measurements
- A61B2562/0209—Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/22—Arrangements of medical sensors with cables or leads; Connectors or couplings specifically adapted for medical sensors
- A61B2562/221—Arrangements of sensors with cables or leads, e.g. cable harnesses
- A61B2562/222—Electrical cables or leads therefor, e.g. coaxial cables or ribbon cables
Definitions
- the invention relates, on the one hand, to an electrode, designed for use on the body of a living being, with a body contact element for applying the electrode to a tissue, with a handpiece connected to the body contact element for gripping the electrode.
- a surgical method widely used in modern medicine is high-frequency surgery (which is also referred to as HF surgery, diathermy or electrocautery):
- HF surgery diathermy or electrocautery
- a significant advantage of this surgical method is that at the same time as the cut is made, bleeding is stopped by closing destroyed vessels.
- an alternating current with a high frequency from around 300 kHz
- HF electrode in order to specifically cut and/or close tissue by means of a desired heat development caused by a high current density at the entry point through denaturation coagulate.
- a neutral electrode with a larger surface area is usually placed on the body for current outlet, with the current density at the neutral electrode due to its larger coverage of the body (compared to the HF electrode). is lower and therefore does not cause burns at this point.
- high-frequency surgery is often used in combination with intraoperative neuromonitoring applications, which is also known as intraoperative neurophysiological monitoring (and often abbreviated as IONM or IOM): used.
- intraoperative neuromonitoring applications which is also known as intraoperative neurophysiological monitoring (and often abbreviated as IONM or IOM): used.
- IONM intraoperative neurophysiological monitoring
- IOM intraoperative neurophysiological monitoring
- at least one, in particular stimulation electrode designed as a needle electrode, and sensors for measuring signals are applied to the body.
- HF leakage current can flow through the intraoperative neuromonitoring electrodes.
- the intraoperative neuromonitoring electrodes are placed closer to a surgical HF handpiece than the neutral electrode of the HF surgical device or if the neutral electrode is not correctly placed on the patient, an HF leakage current can flow through the intraoperative neuromonitoring electrodes and the intraoperative neuromonitoring device .
- HF generators can be used in both mono and bipolar operating modes.
- the riskier mode for intraoperative neuromonitoring is the monopolar operating mode, as the HF current should flow via the neutral electrode.
- HF leakage current can lead to heating of intraoperative neuromonitoring electrodes and their power lines (power connections) that come into contact with the body of a living being. Above a temperature of 42°C, this leads to unwanted burns, especially skin burns, due to the denaturation of the protein in the tissue. Even if the intraoperative neuromonitoring electrodes are not connected to an intraoperative neuromonitoring device, the connection cables of the intraoperative neuromonitoring electrodes can create capacitances, which in turn enable HF leakage currents to flow away, thereby causing potential equalization.
- the object on which this invention is based is therefore to provide an electrode which does not have the aforementioned risks of unwanted burns when using HF surgical procedures and an intraoperative neuromonitoring application at the same time.
- the invention proposes that the electrode is set up for use on the body of a living being and a body contact element for applying the electrode to a tissue, a handpiece connected to the body contact element for gripping the electrode and a throttle for preventing the outflow of HF Leakage currents across the electrode when using the electrode in combination with an HF surgical procedure.
- HF refers to radio frequency, radio frequency ablation and/or radio frequency current. In particular, it refers to frequencies of at least 250 kHz, in particular at least 300 kHz, in particular at least 350 kHz, in particular at least 400 kHz, in particular at least 600 kHz, in particular between 250 kHz and 700 kHz, in particular between 300 kHz and 600 kHz.
- the maximum power of typically used, previously known HF surgery devices is between 200 watts and 360 watts, whereby a higher power is usually required for cutting than for stopping bleeding (coagulation, Coag).
- the throttle prevents unwanted HF leakage currents from flowing out via the electrode according to the invention, although at the same time it is also possible for desired working currents, in particular working currents of a lower frequency lying below a limit frequency, to flow via the electrode according to the invention, that is: can flow out via the throttle.
- desired working currents in particular working currents of a lower frequency lying below a limit frequency
- This can be achieved by setting a specific impedance of the choke, whereby a band pass, in particular a low pass, can be set up, through which a current with a frequency below a set limit frequency can pass almost unweakened and a current that is above the limit frequency is filtered , in particular weakened or blocked.
- the handpiece or at least the outer surfaces of the handpiece consist of an insulating (that is, not electrically conductive) material, such as plastic and/or ceramic.
- an insulating (that is, not electrically conductive) material such as plastic and/or ceramic.
- the electrode according to the invention can be touched even when current flows through the electrode, without any current flowing through the electrode flowing through the person who touches the electrode on the handpiece.
- one or more of the surfaces of the handpiece are designed in such a way that they can be placed essentially entirely or at least with 50% of their area on a surface of a tissue to be pierced and/or resting on the electrode.
- area-shaped means that a surface of the handpiece designed in this way is essentially flat, that is to say flat or approximately flat, for example with a light surface Corrugation, roughened or profiled surface, channels or the like, and in such a way that the surface has an edge area all around that is self-contained.
- cylindrical surfaces essentially, ie also having one or more bulges and/or constrictions which only have edge regions at their ends and have a self-contained surface (in the region of the essentially circular circumference) are excluded.
- a parallel for example a parallel first outer edge
- a defined insertion angle can be (for example from 5 to 90 °, such as from 25 to 35 °, e.g. from 30 °) for the electrode can be specified more precisely, in which the electrode can then also be fixed.
- the handpiece protrudes or rests on the surface of the tissue after the needle has been inserted.
- the protruding part of the handpiece By making the protruding part of the handpiece flat or by folding it over, in particular by folding it around the axis of rotation of the inserted needle, especially with relatively short needles, unwanted protrusion into the space can be prevented.
- a flat section that is approximately perpendicular to a surface whose one edge has a bevel adjoins it at an approximately perpendicular angle. It can be provided that an angle of such a beveled outer edge to an elongated (distal) longitudinal axis of the needle is 5° to 60°, in particular 10° to 40°, in particular 25° to 35°, in particular 30°.
- a “throttle” is the name given to one or more coils or inductors for limiting currents in electrical lines.
- chokes in electrical engineering, it is possible to temporarily store energy in the form of a magnetic field.
- the impedance also known as alternating current resistance
- certain currents can be filtered.
- HF leakage current refers to an unwanted current flow that does not flow as intended, for example via: a neutral electrode of an HF surgical device, but via another power line attached to the body of the living being, such as an electrode and/or a cable line , such as that of an intraoperative neuromonitoring device.
- tissue refers to a tissue of the body, in particular to the surface of a tissue, a living being, preferably a skin tissue, a muscle tissue, a connective tissue, a fatty tissue, one or more nerves, a vessel and/or an organ.
- the term “applying the electrode” can mean contacting a tissue, in particular touching it superficially and/or penetrating or piercing a tissue, such as in particular penetrating or piercing subdermally, so that a current can flow between the tissue and the electrode . In particular, this can mean that at least the body contact element comes into direct contact with the tissue.
- the term “power line” refers to all current-conducting materials through which it is fundamentally possible for HF leakage currents to flow. For example, this can mean a cable line, a wire line, a metal line, an appliance part, a furniture part or similar current-conducting material, liquids and/or capacitive coupling.
- the body contact element of the electrode is designed as a current-conducting needle for inserting, in particular for subdermal piercing, the electrode into the tissue.
- the needle can be solid or hollow. It can be sharpened, beveled or blunt at the distal end (away from the handpiece).
- the shape of the needle itself can vary greatly,
- bipolar needle in this context means that an electrode contains two poles (with charges of different signs), with the needle tip being designed as one pole and a cannula tube placed over it as a second pole.
- the throttle is integrated into the handpiece.
- the HF surgical method preferably has a frequency between 250 kHz and 700 kHz , in particular between 300 kHz and 600 kHZ, in particular at 300, 350, 400 and/or 600 kHz, can be carried out or is carried out, it may be useful: if the choke has an inductance between 1.0 ⁇ H and 100.0 mH, in particular between 100.0 ⁇ H and 20.0 mH, in particular between 1.0 mH and 10.0 mH, in particular between 2.0 mH and 9.0 mH, in particular between 3.0 mH and 8.0 mH, in particular between 4.0 mH and 7.0 mH, preferably 4.7 mH or 6.8 mH.
- the throttle is designed in such a way that the lower limit frequency of the bandpass is at most 7000 kHz, in particular at most 700 kHz, in particular at most 500 kHz, in particular at most 400 kHz, in particular at most 350 kHz, in particular of a maximum of 300 kHz, in particular of a maximum of: 250 kHz, in particular a maximum of 220 kHz, in particular a maximum of 20 kHz, can be generated or arises.
- the limit frequency set up should be set up in such a way that it is below the frequency of the HF surgery procedure.
- the electrode according to the invention is for use with an intraoperative neuromonitoring device is designed to control the stimulation of functions controlled by the somatic and/or the autonomic nervous system, in particular for deriving neurophysiological signals and/or for stimulating functions controlled by the somatic and/or the autonomic nervous system.
- the intraoperative neuromonitoring device is preferably designed to control the stimulation of functions controlled by the somatic and/or the autonomic nervous system, in particular in surgical use, orthopedics, ENT, neurosurgery and/or general surgery. Furthermore, it can be provided that it is designed with a push button and/or is sterilization-stable.
- the body contact element is at least partially made of a metal or several metals, which are particularly approved for humans, and/or that the body contact element has a length between 3.0 mm and 60.0 mm and/or an outer diameter between 0.1 mm and 8.0 mm.
- the needle may be made from one or more conductive materials such as titanium, platinum, iridium and/or tungsten.
- the surface of the needle can be coated, in particular refined, preferably gold-plated, with another conductive material.
- the handpiece of the electrode according to the invention is at least partially designed as an injection molded part and/or as a shrink tube.
- the electrode has two or more body contact elements, preferably in such a way that the body contact elements are integrated into one handpiece and/or firmly connected to it.
- an angle of 90 ° C is included between the one body contact element or elements and the handpiece, in particular for vertical insertion of the body contact element or elements into the tissue.
- the longitudinal axis of the body contact element or the longitudinal axes of the body contact elements is/are aligned coaxially with the longitudinal axis of the handpiece.
- the electrode according to the invention has two or more needles.
- the needles can be arranged on the electrode in such a way that the needles are connected to one handpiece and/or integrated in one handpiece, in particular in a connection area of the handpiece.
- the body contact element or elements and the handpiece in particular the longitudinal axis of the handpiece, there is an angle between 5° and 90°, in particular between 45° and 90°, in particular 45° or 90°, is included, preferably for vertical insertion of the needle or the Needles into the tissue, or that the longitudinal axis of the needle or the longitudinal axes of the needles is/are aligned coaxially to the longitudinal axis, in particular as an extension of the handpiece.
- An embodiment of the electrode according to the invention in which a right angle is included between the needle or needles and the longitudinal axis of the handpiece, can have the advantage that an electrode according to the invention designed in this way can be achieved by applying pressure perpendicularly to the handpiece, simply by means of the needle or the needles can be pressed into a tissue.
- a part of the electrode according to the invention, in particular the at least one needle, is coated or uncoated and/or: that the electrode is designed as a corkscrew electrode, preferably wherein the at least one needle has a corkscrew shape. Furthermore, it can be provided that the electrode is designed to be monopolar or bipolar.
- the electrode according to the invention is suitable for use in combination with an HF surgery method on the body of a living being.
- the electrode according to the invention is suitable for use to prevent unwanted, Burns induced by RF leakage currents on the body of a living being as described herein.
- a system 100 is shown with a specific embodiment of an electrode 1 according to the invention, which is connected by means of a power line 8 to an intraoperative neuromonitoring device 9 for controlling the stimulation, for example of functions controlled by the somatic and / or autonomic nervous system.
- the intraoperative neuromonitoring device 9 can be used to derive neurophysiological signals and/or to stimulate functions controlled by the somatic and/or autonomic nervous system, preferably for surgical use in orthopedics (back), ENT and neurosurgery (head) and General surgery (trunk and extremities), such as in particular in the pelvic area or pelvic floor area.
- Electrode 1 shown which is outlined by the dashed line, is shown in a schematic detailed view.
- the embodiments of the electrode 1, 2, 3, 4, 30 according to the invention according to Figures 1 to 6 each have at least one body contact element 5 for applying the electrode 1, 2, 3, 4, 30 to a tissue 12.
- the body contact element 5 is designed as a needle for insertion, in particular for piercing, preferably for subdermal piercing, into the tissue 12.
- the at least one body contact element 5 is made of at least one conductive material and is connected to a power line 8 via a throttle 7.
- the electrode 1, 2, 3, 4, 30 For easier handling of the electrode 1, 2, 3, 4, 30 according to the invention, it is generally provided that it has a handpiece 6 connected to the body contact element 5, suitable for Gripping the electrode 1, 2, 3, 4, 30.
- the electrode 1, 2, 3, 4, 30 has a throttle 7.
- the throttle 7 is as in the Figures 1 to 3 as in Figures 5 and 6 is shown, housed inside the handpiece 6. In Figure 4 Although no throttle is shown (since the Figure 4 not shown as a sectional view).
- a throttle 7 is also provided inside the handpiece 6 in order to prevent HF leakage currents from flowing out via the electrode 1, 2, 3, 4, 30.
- the throttle 7 is preferably integrated or inserted as a line adapter in the power line 8 or can be used subsequently, the throttle 7 being connected in series in the power line 8.
- the power line 8 for connecting the electrode 1 according to the invention can be designed as an integral part of the electrode 1, 2, 3, 4, 30 according to the invention, in particular attached to the handpiece 6, or with the handpiece 6 via one or more contact elements (not shown), in particular via a plug and a socket, can be connected, in particular in such a way that the power line 8 can be detachably connected to the handpiece 6.
- the power line 8 is preferably designed as a cable line that is insulated from the outside.
- the total length of the power line 8 of the electrode is between 0.10 m and 7.0 m, in particular between 0.25 m and 5.0 m, in particular between 0.5 and 4.5 m, in particular between 0.8 m and 4.0 m, in particular between 1.0 and 3.5 m, preferably between 0.12 m and 3.0 m, preferably between 1.2 m and 1.5 m.
- the choke 7 can have an inductance between 1.0 ⁇ H and 100.0 mH, in particular between 100.0 ⁇ H and 20.0 mH, in particular between 1.0 mH and 10.0 mH, in particular between 2.0 mH and 9 .0 mH, in particular between 3.0 mH and 8.0 mH, in particular between 4.0 mH and 7.0 mH, preferably 4.7 mH or 6.8 mH.
- the throttle 7 of the electrode 1, 2, 3, 4, 30 according to the invention is preferably set up in such a way that a bandwidth filter for generating a resonance frequency of at most 400 kHz, in particular of at most 300 kHz, in particular of at most 250 kHz, in particular at most 220 kHz, producible is or arises.
- Particularly suitable metals for production can be, for example, stainless steel and/or platinum-iridium.
- the body contact element 5 is coated.
- the body contact element 5, which is shaped as a needle, can have different lengths that can be adapted to the intended application. In particular, it can be provided that the body contact element 5 has a length between 3.0 mm and 60.0 mm and/or an outer diameter between 0.1 mm and 8.0 mm.
- the handpiece 6 can, for example, be designed as a housing, which is made of plastic, for example. It can be particularly advantageous if at least part of the handpiece 6 is an injection molded part 10 and/or a shrink tube 11 (see Figure 5 ) is executed. It can also be advantageous if the handpiece 6 has a grip surface 15 for easier holding, gripping and placing of the electrode 1, 2, 3, 4, 30.
- the grip surface 15 can be designed, for example, as a non-slip surface, preferably as a rubberized surface.
- the electrode 1, 2, 3, 4, 30 according to the invention is made from materials that are suitable for sterilization and/or autoclaving. Furthermore, it can be provided that the electrode 1, 2, 3, 4, 30 according to the invention is designed as a disposable product that is disposed of after use.
- the electrode 2 according to the invention is provided that the longitudinal axes 14 of the body contact elements 5 are aligned coaxially to the longitudinal axis 13 of the handpiece.
- an angle of 90 ° C is included between the body contact elements 5 and the handpiece 6.
- This type of alignment makes it possible for the electrode 3 to be placed on the surface of a tissue 12 and to be inserted almost vertically into the tissue 12 by means of its body contact elements 5 designed as needles by applying pressure to the handpiece 6, in particular by applying pressure with a thumb is.
- FIG. 5 An embodiment of the invention is shown, in which the handpiece 6 of the electrode 4 is designed as a shrink tube 11.
- the body contact element 5 is designed as a needle in a spiral corkscrew shape, the tip of this body contact element 5 being beveled and tapered.
- the body contact element 5 is connected to the throttle 7, the throttle 7 being in the Handpiece 6 is housed.
- This configuration has the advantage that the corkscrew electrode can penetrate tissue, in particular the skin, easily and in a direction defined by the spiral shape by rotating it around the longitudinal axis clockwise or counterclockwise (depending on the orientation of the individual turns). can be applied to the tissue, especially the skin.
- a disadvantage of such conventional electrodes 19 and systems consisting of an intraoperative neuromonitoring device 9 and a conventional electrode 19, which is applied to the body of a living being, in particular a human, is that that, for example, when used in combination with an HF surgery method, unwanted burns on the tissue 12 of the body can occur due to the flow of HF leakage currents via a power line 8 of the conventional electrode 19.
- FIG. 7 to 9 a specific embodiment of a non-Z retrofit element 20 according to the invention for use as a line adapter in a power line 8 is shown.
- the retrofit element 20 has a housing 18 and can be used as a line adapter in particular by means of two contact elements 21 designed as crimp connections 24 at two free ends 23 of a power line 8.
- the retrofit element 20 can be inserted as easily as possible into a continuous power line 8, it can be provided that it has a cutting device 22, in particular an at least partially conductive cutting device 22, for cutting and/or removing a part of the power line 8, wherein through the cutting device 22 two free ends 23 of the power line 8 can be generated, to which the two contact elements 21 in turn attach to connect the retrofit element 20 as a line adapter with the power line 8.
- the contact elements 21 and the cutting device 22 can, as in the Figures 7 to:9 is shown, can be designed as a combined contact cutting device, for example in the form of a shearing unit, in particular as one or more, preferably two, current-conducting shearing plates.
- the uncut power line 8 can be inserted into the retrofit element 20 in the open position and by closing the retrofit element 20, the power line 8 can be cut using the shear plate or shear plates and at the same time a current flow can be produced via the throttle 7 through the shear plate or shear plates.
- the retrofit element 20 is designed as a retrofit clip, wherein the two housing parts 25, 26 can be connected so that they can move relative to one another by means of at least one hinge, so that the retrofit element 20 can be opened and closed by means of the at least one hinge or can be connected or are connected to one another by means of a clip mechanism, the retrofit element 20 being able to be moved into a closed position, in particular reversibly, by clipping the two housing parts 25, 26 together.
- the retrofit element 20 designed as a retrofit clip is a combined cutting-contact device (which can be designed in such a way as has already been described above) for cutting and removing a severed part 28 of the power line 8 and for simultaneous connection of two free ends 23 of the interrupted power line.
- a current flow is only possible through the throttle 7 of the retrofit element 20.
- a cutting device 22 can be actuated by an actuating force generated when the two housing parts 25, 26 are closed, whereby the power line::8 can be severed at least in one place by means of the cutting device 22 and thus at least two free ones Ends 23 of the power line 8 can be generated. It can also be provided that an intermediate piece or part 28 of the power line 8 is cut out by the cutting device 22.
- clamping devices 27 which are preferably designed on the housing 18, which in the closed position of the housing 18 grip the part of the power line 8 to the body contact element 5 and the part of the power line 8 to the IOM system, the free ends 23 of the power line 8 are in the Retrofit element: 20 fixed.
- the clamping devices 27 can, for example, be designed as passage openings, preferably as round or oval passage openings, on the housing 18.
- the two contact elements 21 connect the throttle 7 as a line intermediate piece of the power line 8 with the two free ends 23.
- the current then only flows via the shear plates and thus via the throttle 7 flows.
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Description
Die Erfindung betrifft zum einen eine Elektrode, eingerichtet zur Anwendung am Körper eines Lebewesens, mit einem Körperkontaktelement zum Anlegen der Elektrode an ein Gewebe, mit einem mit dem Körperkontaktelement verbundenen Handstück zum Greifen der Elektrode.The invention relates, on the one hand, to an electrode, designed for use on the body of a living being, with a body contact element for applying the electrode to a tissue, with a handpiece connected to the body contact element for gripping the electrode.
Eine in der modernen Medizin weitreichend eingesetzte Operationsmethode ist die Hochfrequenz-Chirurgie (die auch als HF-Chirurgie, Diathermie oder Elektrokauterisation bezeichnet wird): Ein wesentlicher Vorteil dieser Operationsmethode, beispielsweise gegenüber einer herkömmlichen Verwendung eines Skalpells, besteht darin, dass gleichzeitig mit dem Schnitt eine Blutungsstillung durch einen Verschluss von zerstörten Gefäßen erfolgt.Technisch wird dies dadurch umgesetzt, dass ein Wechselstrom mit hoher Frequenz (ab etwa 300 kHz) mittels einer HF-Elektrode durch den Körper geleitet wird, um Gewebe mittels einer gewollten, durch eine hohe Stromdichte hervorgerufenen Hitzeentwicklung an der Eintrittsstelle gezielt durch Denaturierung zu schneiden und/oder zu koagulieren. Um eine ungewollte Schädigung anderer Gewebebereiche des Körpers zu verhindern, ist bei monopolarer HF-Anwendung in der Regel eine großflächiger ausgeformte Neutralelektrode zum Stromaustritt am Körper angelegt, wobei die Stromdichte an der Neutralelektrode aufgrund ihrer großflächigeren Abdeckung des Körpers (im Vergleich zur HF-Elektrode) geringer ist und an dieser Stelle daher keine Verbrennungen hervorruft.A surgical method widely used in modern medicine is high-frequency surgery (which is also referred to as HF surgery, diathermy or electrocautery): A significant advantage of this surgical method, for example compared to the conventional use of a scalpel, is that at the same time as the cut is made, bleeding is stopped by closing destroyed vessels. Technically, this becomes implemented in that an alternating current with a high frequency (from around 300 kHz) is passed through the body using an HF electrode in order to specifically cut and/or close tissue by means of a desired heat development caused by a high current density at the entry point through denaturation coagulate. In order to prevent unwanted damage to other tissue areas of the body, with monopolar HF application a neutral electrode with a larger surface area is usually placed on the body for current outlet, with the current density at the neutral electrode due to its larger coverage of the body (compared to the HF electrode). is lower and therefore does not cause burns at this point.
Um während eines solchen hochfrequenz-chirurgischen Eingriffs überprüfen zu können, ob die Integrität von Nerven und neuronalen Bahnen oder Gehirnfunktionen besteht beziehungsweise durch den Eingriff versehrt wurde, wird die Hochfrequenz-Chirurgie häufig in Kombination mit intraoperativen Neuromonitoring-Anwendungen, was auch als intraoperatives neurophysiologisches Monitoring bezeichnet wird (und häufig nur als IONM oder IOM abgekürzt wird): eingesetzt. Um eine kontinuierliche und gleichzeitig mit dem HF-chirurgischen Eingriff stattfindende Kontrolle der Stimulierbarkeit, beispielsweise von durch das somatische und/oder vegetative Nervensystem gesteuerten Funktionen, zu gewährleisten, werden mindestens jeweils eine, insbesondere als Nadelelektrode ausgebildete Stimulationselektrode, und Sensoren zur Messung von Signalen an den Körper angelegt.In order to be able to check during such a high-frequency surgical procedure whether the integrity of nerves and neuronal pathways or brain functions exists or has been damaged by the procedure, high-frequency surgery is often used in combination with intraoperative neuromonitoring applications, which is also known as intraoperative neurophysiological monitoring (and often abbreviated as IONM or IOM): used. In order to ensure continuous control of the stimulation, for example of functions controlled by the somatic and/or autonomic nervous system, which takes place simultaneously with the HF surgical procedure, at least one, in particular stimulation electrode designed as a needle electrode, and sensors for measuring signals are applied to the body.
Durch die gleichzeitige Verwendung der HF-Chirurgie in Kombination mit intraoperativen Neuromonitoring besteht das Risiko, dass ein HF-Leckstrom über die intraoperativen Neuromonitoring-Elektroden abfließen kann. Sind die intraoperativen Neuromonitoring-Elektroden beispielsweise näher an einem chirurgischen HF-Handstück als die Neutralelektrode des HF-Chirurgiegerätes angesetzt oder ist die Neutralelektrode nicht korrekt am Patienten platziert, kann ein HF-Leckstrom über die intraoperativen Neuromonitoring-Elektroden und das intraoperative Neuromonitoring-Gerät abfließen. HF-Generatoren können sowohl in mono- als auch in bipolarer Betriebsart genutzt werden. Der für das intraoperative Neuromonitoring risikoreichere Modus ist die monopolare Betriebsart, da der HF-Strom hierbei über die Neutralelektrode abfließen soll. Aufgrund der wesentlich kleineren Oberfläche der intraoperativen Neuromonitoring-Elektroden verglichen zur Neutralelektrode kann es durch HF-Leckstrom zu einer Erhitzung an intraoperativen Neuromonitoring-Elektroden sowie deren den Körper eines Lebewesensberührenden Stromleitungen (Stromanschlüssen) kommen. Ab einerTemperatur von 42°C führt dies durch die Denaturierung des Eiweißes des Gewebes zu ungewollten Verbrennungen, insbesondere Hautverbrennungen. Selbst wenn die intraoperativen Neuromonitoring-Elektroden nicht mit einem intraoperativen Neuromonitoring-Gerät verbunden sind, können durch die Anschlusskabel der intraoperativen Neuromonitoring-Elektroden Kapazitäten entstehen, die wiederum ein Abfließen von HF-Leckströmen ermöglichen, dadurch dass eine Potentialangleichung stattfindet.Due to the simultaneous use of HF surgery in combination with intraoperative neuromonitoring, there is a risk that an HF leakage current can flow through the intraoperative neuromonitoring electrodes. For example, if the intraoperative neuromonitoring electrodes are placed closer to a surgical HF handpiece than the neutral electrode of the HF surgical device or if the neutral electrode is not correctly placed on the patient, an HF leakage current can flow through the intraoperative neuromonitoring electrodes and the intraoperative neuromonitoring device . HF generators can be used in both mono and bipolar operating modes. The riskier mode for intraoperative neuromonitoring is the monopolar operating mode, as the HF current should flow via the neutral electrode. Due to the significantly smaller surface area of the intraoperative neuromonitoring electrodes compared to the neutral electrode, HF leakage current can lead to heating of intraoperative neuromonitoring electrodes and their power lines (power connections) that come into contact with the body of a living being. Above a temperature of 42°C, this leads to unwanted burns, especially skin burns, due to the denaturation of the protein in the tissue. Even if the intraoperative neuromonitoring electrodes are not connected to an intraoperative neuromonitoring device, the connection cables of the intraoperative neuromonitoring electrodes can create capacitances, which in turn enable HF leakage currents to flow away, thereby causing potential equalization.
Die dieser Erfindung zugrunde liegende Aufgabe besteht also darin, eine Elektrode bereitzustellen, welche die zuvor genannten Risiken einer ungewollten Verbrennung bei einem gleichzeitigen Einsatz von HF-Chirurgie-Verfahren und einer intraoperativen Neuromonitoring-Anwendung nicht aufweist.The object on which this invention is based is therefore to provide an electrode which does not have the aforementioned risks of unwanted burns when using HF surgical procedures and an intraoperative neuromonitoring application at the same time.
Diese Aufgabe wird durch die Merkmale des Anspruchs 1 gelöst. Insbesondere wird erfindungsgemäßzur Lösung der Aufgabe vorgeschlagen, dass die Elektrode zur Anwendung am Körper eines Lebewesens eingerichtet ist und ein Körperkontaktelement zum Anlegen der Elektrode an ein Gewebe, ein mit dem Körperkontaktelement verbundenes Handstück zum Greifen der Elektrode und eine Drossel zum Verhindern des Abfließens von HF-Leckströmen über die Elektrode bei der Verwendung der Elektrode in Kombination mit einem HF-Chirurgie-Verfahren aufweist.This task is solved by the features of
Die nachfolgenden Definitionen allgemeiner Begriffe können einzeln, zu mehreren oder alle zum Ersetzen der allgemeinen Begriffe herangezogen werden. So werden bevorzugte Ausführungsformen der Erfindung definiert.The following definitions of general terms can be used individually, in groups or all to replace the general terms. This is how preferred embodiments of the invention are defined.
Die Abkürzung "HF" bezeichnet im Kontext der Anmeldung Hochfrequenz, Hochfrequenzablation und/oder Hochfrequenzstrom. Insbesondere bezieht sie sich auf Frequenzen von mindestens 250 kHz, insbesondere mindestens 300 kHz, insbesondere mindestens 350 kHz, insbesondere von mindestens 400 kHz, insbesondere von mindestens 600 kHz, insbesondere zwischen 250 kHz und 700 kHz, insbesondere zwischen 300 kHz und 600 kHz. Die maximale Leistung typischerweise eingesetzter, vorbekannter HF-Chirurgie-Geräte beträgt zwischen 200Watt und 360 Watt, wobei in der Regel zum Schneiden (Cut) eine höhere Leistung als zur Blutstillung (Koagulation, Coag) notwendig ist.In the context of the application, the abbreviation “HF” refers to radio frequency, radio frequency ablation and/or radio frequency current. In particular, it refers to frequencies of at least 250 kHz, in particular at least 300 kHz, in particular at least 350 kHz, in particular at least 400 kHz, in particular at least 600 kHz, in particular between 250 kHz and 700 kHz, in particular between 300 kHz and 600 kHz. The maximum power of typically used, previously known HF surgery devices is between 200 watts and 360 watts, whereby a higher power is usually required for cutting than for stopping bleeding (coagulation, Coag).
Durch die Drossel wird hierbei verhindert, dass ungewollte HF-Leckströme über die erfindungsgemäße Elektrode abfließen können, wobei es daneben allerdings gleichzeitig möglich ist, dass gewollte Arbeitsströme, insbesondere Arbeitsströme einer niedrigeren, unterhalb einer Grenzfrequenz liegenden Frequenz, über die erfindungsgemäße Elektrode, das heißt: über die Drossel, abfließen können. Dies kann durch die Einstellung einer bestimmten Impedanz der Drossel erreicht werden, wodurch ein Bandpass, insbesondere ein Tiefpass, einrichtbar ist, durch welchen ein Strom mit einer Frequenz unterhalb einer eingerichteten Grenzfrequenz annähernd ungeschwächt passieren kann und ein Strom, der über der Grenzfrequenz liegt, gefiltert, insbesondere abgeschwächt oder gesperrt, wird.The throttle prevents unwanted HF leakage currents from flowing out via the electrode according to the invention, although at the same time it is also possible for desired working currents, in particular working currents of a lower frequency lying below a limit frequency, to flow via the electrode according to the invention, that is: can flow out via the throttle. This can be achieved by setting a specific impedance of the choke, whereby a band pass, in particular a low pass, can be set up, through which a current with a frequency below a set limit frequency can pass almost unweakened and a current that is above the limit frequency is filtered , in particular weakened or blocked.
Es kann z.B. vorgesehen sein, dass das Handstück oder zumindest die Außenflächen des Handstücks aus einem isolierenden (das bedeutet nicht stromleitenden) Material, wie Kunststoff und/oder Keramik besteht. Dadurch kann ein Berühren der erfindungsgemäßen Elektrode auch bei Stromfluss durch die Elektrode erfolgen, ohne dass ein über die Elektrode abfließender Strom durch denjenigen abfließt, der die Elektrode am Handstück berührt. Es kann beispielsweise weiter vorgesehen sein, dass eine oder mehrere der Oberflächendes Handstücks derart ausgestaltet sind, dass sie im Wesentlichen ganz oder mindestens mit 50 % ihrer Fläche an einer zu durchstechenden und/oder an der Elektrode anliegenden Oberfläche eines Gewebes anlegbar ist/sind.For example, it can be provided that the handpiece or at least the outer surfaces of the handpiece consist of an insulating (that is, not electrically conductive) material, such as plastic and/or ceramic. This means that the electrode according to the invention can be touched even when current flows through the electrode, without any current flowing through the electrode flowing through the person who touches the electrode on the handpiece. For example, it can further be provided that one or more of the surfaces of the handpiece are designed in such a way that they can be placed essentially entirely or at least with 50% of their area on a surface of a tissue to be pierced and/or resting on the electrode.
Unter "flächenförmig ausgebildet" ist im Kontext der Anmeldung zu verstehen, dass eine derart ausgestaltete Oberfläche des Handstücks im Wesentlichen eben ausgestaltet ist, das heißt plan oder annähernd plan, z.B. mit leichter Wellung, angerauter oder profilierter Oberfläche, Kanälen oder dergleichen, und dergestalt, dass die Fläche rundherum einen Kantenbereich aufweist, der in sich geschlossen ist. Mit anderen Worten, (im Wesentlichen, d.h. z.B. auch ein oder mehrere Ausbuchtungen und/oder Einschnürungen aufweisende) zylindrische Oberflächen, die nur an ihren Enden Kantenbereiche aufweisen und eine (im Bereich des im wesentlichen kreisförmigen Umfangs) in sich geschlossene Oberfläche aufweisen, sind ausgeschlossen.In the context of the application, “area-shaped” means that a surface of the handpiece designed in this way is essentially flat, that is to say flat or approximately flat, for example with a light surface Corrugation, roughened or profiled surface, channels or the like, and in such a way that the surface has an edge area all around that is self-contained. In other words, cylindrical surfaces (essentially, ie also having one or more bulges and/or constrictions) which only have edge regions at their ends and have a self-contained surface (in the region of the essentially circular circumference) are excluded.
Ein Kantenbereich kann im Falle mehrerer, insbesondere zweier, flächenförmig ausgestalteter Oberflächen des Handstücks eine größte Tiefe (gemessen insbesondere als Erstreckung senkrecht zu einer mittleren Lage der Ebene der Oberflächen) aufweisen, die geringer ist, als die längste Breite der flächenförmig ausgestalteten Oberfläche senkrecht zur gedachten geraden Fortsetzung der Längsachse der Nadel im Verbindungsbereich (= an der Stelle, in der die Nadel in das Handstück einmündet) mit dem Handstück, beispielsweise ist diese Breite drei- bis zwanzig-, wie 3,5- bis 15-, z.B. 4-: bis 12-mal so groß wie die größte Tiefe des Kantenbereichs.In the case of several, in particular two, flat surfaces of the handpiece, an edge region can have a greatest depth (measured in particular as an extension perpendicular to an average position of the plane of the surfaces), which is less than the longest width of the flat surface perpendicular to the imaginary one straight continuation of the longitudinal axis of the needle in the connection area (= at the point where the needle enters the handpiece) with the handpiece, for example this width is three to twenty, such as 3.5 to 15, e.g. 4: up to 12 times the greatest depth of the edge area.
Durch die Wahl eines Winkels einer relativ (insbesondere bezogen auf eine verlängert gedachte Längsachse der Nadel im außerhalb (= distal) des Punkts des Übergangs von der Nadel in das Handstück) zu einer mit dem Handstück verbundenen Nadel gelegenen Parallelen (zum Beispiel einer parallelen ersten Außenkante des Handstücks) abgeschrägten Außenkante des Handstücks, die derart abgeschrägt ist, dass sie in Richtung zur Nadel im Verbindungsbereich näher an der gedachten geraden Verlängerung der Längsachse der Nadel in das Handstück hinein gelegen ist, als in einem dem Verbindungsbereich abgewandten Bereich, kann ein definierter Einstechwinkel (beispielsweise von 5 bis 90 °, wie von 25 bis 35 °, z.B. von 30 °) für die Elektrode genauer festgelegt werden, in dem die Elektrode dann auch fixiert werden kann.By choosing an angle of a parallel (for example a parallel first outer edge) relative to a needle connected to the handpiece (in particular in relation to an imaginary extended longitudinal axis of the needle outside (= distal) of the point of transition from the needle to the handpiece). of the handpiece) beveled outer edge of the handpiece, which is beveled in such a way that it is located in the direction of the needle in the connection area closer to the imaginary straight extension of the longitudinal axis of the needle into the handpiece than in an area facing away from the connection area, a defined insertion angle can be (for example from 5 to 90 °, such as from 25 to 35 °, e.g. from 30 °) for the electrode can be specified more precisely, in which the electrode can then also be fixed.
Es kann vorgesehen sein, dass das Handstück nach Einbringen der Nadel hervorsteht oder an der Oberfläche des Gewebes anliegt. Durch eine flache Ausführung des hervorstehenden Teils des Handstücks oder durch Umlegen, insbesondere durch Klappen um die Rotationsachse der eingestochenen Nadel, insbesondere bei relativ kurzen Nadeln, kann ein ungewolltes Abstehen in den Raum verhindert werden. Ebenso kann vorgesehen sein, dass sich ein zu einer Fläche, deren eine Kante eine Abschrägung aufweist, in einem annähernd senkrechten Winkel annähernd senkrechter flächiger Abschnitt anschließt. Es kann vorgesehen sein, dass ein Winkel einer derart abgeschrägten Außenkante zu einer verlängert gedachten (distalen) Längsachse der Nadel 5° bis 60°, insbesondere 10° bis 40°, insbesondere 25° bis 35°, insbesondere 30° beträgt.It can be provided that the handpiece protrudes or rests on the surface of the tissue after the needle has been inserted. By making the protruding part of the handpiece flat or by folding it over, in particular by folding it around the axis of rotation of the inserted needle, especially with relatively short needles, unwanted protrusion into the space can be prevented. It can also be provided that a flat section that is approximately perpendicular to a surface whose one edge has a bevel adjoins it at an approximately perpendicular angle. It can be provided that an angle of such a beveled outer edge to an elongated (distal) longitudinal axis of the needle is 5° to 60°, in particular 10° to 40°, in particular 25° to 35°, in particular 30°.
Als "Drossel" bezeichnet man eine oder mehrere Spulen, beziehungsweise Induktivitäten zur Begrenzung von Strömen in elektrischen Leitungen. Durch die Verwendung von Drosseln ist es in der Elektrotechnik möglich, Energie in Form eines Magnetfeldes zwischenzuspeichern. Durch den Einsatz von Drosseln in elektrischen Leitungen kann die Impedanz (auch als Wechselstromwiderstand bezeichnet) angepasst werden und es können bestimmte Ströme gefiltert werden.A “throttle” is the name given to one or more coils or inductors for limiting currents in electrical lines. By using chokes in electrical engineering, it is possible to temporarily store energy in the form of a magnetic field. By using chokes in electrical lines, the impedance (also known as alternating current resistance) can be adjusted and certain currents can be filtered.
Als "HF-Leckstrom" wird ein ungewollter Stromfluss bezeichnet, welcher nicht wie vorgesehen beispielsweise über: eine Neutralelektrode eines HF-Chirurgie-Gerätes abfließt, sondern über eine andere, am Körper des Lebewesens anliegenden Stromleitung, wie beispielsweise eine Elektrode und/oder eine Kabelleitung, wie die eines intraoperativen Neuromonitoring-Geräts.The term “HF leakage current” refers to an unwanted current flow that does not flow as intended, for example via: a neutral electrode of an HF surgical device, but via another power line attached to the body of the living being, such as an electrode and/or a cable line , such as that of an intraoperative neuromonitoring device.
Im Kontext dieser Anmeldung umfasst der Begriff "Lebewesen" alle Tiere und Menschen. Insbesondere sind damit Säugetiere, Vögel, Amphibien, Reptilien und/oder Fische bezeichnet. Insbesondere bezieht sich der Begriff "Lebewesen" auf den Menschen und/oder andere Säugetiere. Der Begriff "Gewebe" bezieht sich auf ein Gewebe des Körpers, insbesondere auf die Oberfläche eines Gewebes, eines Lebewesens, vorzugsweise auf ein Hautgewebe, ein Muskelgewebe, ein Bindegewebe, ein Fettgewebe, einen oder mehrere Nerven, ein Gefäß und/oder ein Organ. Der Begriff "Anlegen der Elektrode" kann im Zusammenhang der Anmeldung ein Gewebe kontaktieren, insbesondere oberflächlich berühren und/oder in ein Gewebe eindringen oder einstechen, wie insbesondere subdermal eindringen oder einstechen, bedeuten, so dass ein Strom zwischen dem Gewebe und der Elektrode fließen kann. Insbesondere kann damit gemeint sein, dass zumindest das Körperkontaktelement mit dem Gewebe direkt in Kontakt tritt. Der Begriff "Stromleitung" bezeichnet im Kontext der Anmeldung alle stromleitenden Materialien, über welche grundsätzlich ein Abfließen von HF-Leckströmen möglich ist. Beispielsweise kann damit eine Kabelleitung, eine Drahtleitung, eine Metallleitung, ein Geräteteil, ein Möbelteil oder dergleichen stromleitendes Material, Flüssigkeiten und/oder kapazitive Kopplung gemeint sein.In the context of this application, the term “living beings” includes all animals and humans. In particular, this refers to mammals, birds, amphibians, reptiles and/or fish. In particular, the term “living being” refers to humans and/or other mammals. The term “tissue” refers to a tissue of the body, in particular to the surface of a tissue, a living being, preferably a skin tissue, a muscle tissue, a connective tissue, a fatty tissue, one or more nerves, a vessel and/or an organ. In the context of the application, the term “applying the electrode” can mean contacting a tissue, in particular touching it superficially and/or penetrating or piercing a tissue, such as in particular penetrating or piercing subdermally, so that a current can flow between the tissue and the electrode . In particular, this can mean that at least the body contact element comes into direct contact with the tissue. In the context of the application, the term “power line” refers to all current-conducting materials through which it is fundamentally possible for HF leakage currents to flow. For example, this can mean a cable line, a wire line, a metal line, an appliance part, a furniture part or similar current-conducting material, liquids and/or capacitive coupling.
Erfindungsgemäß wird das Körperkontaktelement der Elektrode als stromleitfähige Nadel zum Einführen, insbesondere zum subdermalen Einstechen, der Elektrode in das Gewebe ausgestaltet. Die Nadel kann massiv oder hohl ausgebildet sein. Sie kann am distalen (vom Handstück entfernten) Ende angespitzt, abgeschrägt oder stumpf sein. Die Form der Nadel selbst kann stark variieren,According to the invention, the body contact element of the electrode is designed as a current-conducting needle for inserting, in particular for subdermal piercing, the electrode into the tissue. The needle can be solid or hollow. It can be sharpened, beveled or blunt at the distal end (away from the handpiece). The shape of the needle itself can vary greatly,
sie kann beispielsweise gerade, ein- oder mehrfach gebogen, wendelförmig, insbesondere korkenzieherförmig, mit einem Haken, insbesondere am distalen Ende, mit glatter oder mit profilierter, beispielsweise mit Widerhaken versehener, Oberfläche oder in Form einer bipolaren Nadel ausgebildet sein. Der Begriff bipolare Nadel bedeutet in diesem Zusammenhang, dass eine Elektrode zwei Pole (mit Ladung unterschiedlichen Vorzeichens) enthält, wobei die Nadelspitze als ein Pol und ein übergestülptes Kanülenrohr als ein zweiter Pol ausgestaltet ist.For example, it can be straight, bent once or several times, helical, in particular corkscrew-shaped, with a hook, in particular at the distal end, with a smooth or with a profiled surface, for example provided with barbs, or in the form of a bipolar needle. The term bipolar needle in this context means that an electrode contains two poles (with charges of different signs), with the needle tip being designed as one pole and a cannula tube placed over it as a second pole.
Erfindungsgemäß wird die Drossel in das Handstück integriert.According to the invention, the throttle is integrated into the handpiece.
Zur Einstellung eines zur Lösung der Aufgabe geeigneten Bandpasses, welcher insbesondere das Abfließen von HF-Leckströmen über die erfindungsgemäße Elektrode während des Einsatzes eines HF-Chirurgie-Verfahrens verhindert, wenn das HF-Chirurgie-Verfahren vorzugsweise mit einer Frequenz zwischen 250 kHz und 700 kHZ, insbesondere zwischen 300 kHz und 600 kHZ, insbesondere bei 300, 350, 400 und/oder 600 kHz, durchführbar ist oder durchgeführt wird, kann es zweckmäßig sein,:wenn die Drossel eine Induktivität zwischen 1,0 µH und 100,0 mH, insbesondere zwischen 100,0 µH und 20,0 mH, insbesondere zwischen 1,0 mH und 10,0 mH, insbesondere zwischen 2,0 mH und 9,0 mH, insbesondere zwischen 3,0 mH und 8,0 mH, insbesondere zwischen 4,0 mH und 7,0 mH, vorzugsweise von 4,7 mH oder 6,8 mH aufweist.To set a band pass suitable for solving the problem, which in particular prevents the flow of HF leakage currents via the electrode according to the invention during the use of an HF surgical method, if the HF surgical method preferably has a frequency between 250 kHz and 700 kHz , in particular between 300 kHz and 600 kHZ, in particular at 300, 350, 400 and/or 600 kHz, can be carried out or is carried out, it may be useful: if the choke has an inductance between 1.0 µH and 100.0 mH, in particular between 100.0 µH and 20.0 mH, in particular between 1.0 mH and 10.0 mH, in particular between 2.0 mH and 9.0 mH, in particular between 3.0 mH and 8.0 mH, in particular between 4.0 mH and 7.0 mH, preferably 4.7 mH or 6.8 mH.
Insbesondere kann es also zweckmäßig sein, wenn die Drossel derart ausgestaltet ist, dass die untere Grenzfrequenz des Bandpasses von höchstens 7000 kHz, insbesondere von höchstens 700 kHz, insbesondere von höchstens 500 kHz, insbesondere von höchstens 400 kHz, insbesondere von höchstens 350 kHz, insbesondere von höchstens 300 kHz, insbesondere von höchstens: 250 kHz, insbesondere höchstens 220 kHz, insbesondere höchstens 20 kHz, erzeugbar ist oder entsteht. Auf diese Weise kann gewährleistet werden, dass nur die Ströme im Arbeitsfrequenzbereich der erfindungsgemäßen Elektrode unterhalb der eingerichteten Grenzfrequenz durch die erfindungsgemäße Elektrode ableitbar sind. Die eingerichtete Grenzfrequenz soll derart eingerichtet sein dass diese unterhalb der Frequenz des HF-Chirurgie Verfahrens liegt.In particular, it can be useful if the throttle is designed in such a way that the lower limit frequency of the bandpass is at most 7000 kHz, in particular at most 700 kHz, in particular at most 500 kHz, in particular at most 400 kHz, in particular at most 350 kHz, in particular of a maximum of 300 kHz, in particular of a maximum of: 250 kHz, in particular a maximum of 220 kHz, in particular a maximum of 20 kHz, can be generated or arises. In this way it can be ensured that only the currents in the working frequency range of the electrode according to the invention below the set limit frequency can be derived through the electrode according to the invention. The limit frequency set up should be set up in such a way that it is below the frequency of the HF surgery procedure.
Es kann vorgesehen sein, dass die erfindungsgemäße Elektrode zur Verwendung mit einem Intraoperativen-Neuromonitoring-Gerät zur Kontrolle der Stimulierbarkeit von durch das somatische und/oder das vegetative Nervensystem gesteuerten Funktionen, insbesondere zur Ableitung neurophysiologischer Signale und/oder zur Stimulation von durch das somatische und/oder das vegetative Nervensystem gesteuerten Funktionen ausgebildet ist. Vorzugsweise ist das Intraoperativen-Neuromonitoring-Gerät zur Kontrolle der Stimulierbarkeit von durch das somatische und/oder das vegetative Nervensystem gesteuerten Funktionen, insbesondere in der chirurgischen Anwendung, Orthopädie, HNO, Neurochirurgie und/oder Allgemeinchirurgie ausgebildet. Des Weiteren kann vorgesehen sein, dass sie mit einen Druckknopf und/oder sterilisierungsstabil ausgebildet ist.It can be envisaged that the electrode according to the invention is for use with an intraoperative neuromonitoring device is designed to control the stimulation of functions controlled by the somatic and/or the autonomic nervous system, in particular for deriving neurophysiological signals and/or for stimulating functions controlled by the somatic and/or the autonomic nervous system. The intraoperative neuromonitoring device is preferably designed to control the stimulation of functions controlled by the somatic and/or the autonomic nervous system, in particular in surgical use, orthopedics, ENT, neurosurgery and/or general surgery. Furthermore, it can be provided that it is designed with a push button and/or is sterilization-stable.
Zum einfachen und sicheren Anlegen der erfindungsgemäßen Elektrode an einem Gewebe kann es zweckmäßig sein, wenn das Körperkontaktelement zumindest teilweise aus einem Metall oder mehreren Metallen, welche insbesondere für den Menschen zugelassenen sind, hergestellt ist und/oder dass das Körperkontaktelement eine Länge zwischen 3,0 mm und 60,0 mm und/oder einen Außendurchmesser zwischen 0,1 mm und 8,0 mm aufweist. Vorzugsweise kann die Nadel aus einem oder mehreren leitenden Materialien, wie Titan, Platin, Iridium und/oder Wolfram hergestellt sein. Die Oberfläche der Nadel kann mit einem weiteren leitfähigen Material beschichtet, insbesondere veredelt, vorzugsweise vergoldet, sein.For simple and safe application of the electrode according to the invention to a tissue, it may be expedient if the body contact element is at least partially made of a metal or several metals, which are particularly approved for humans, and/or that the body contact element has a length between 3.0 mm and 60.0 mm and/or an outer diameter between 0.1 mm and 8.0 mm. Preferably, the needle may be made from one or more conductive materials such as titanium, platinum, iridium and/or tungsten. The surface of the needle can be coated, in particular refined, preferably gold-plated, with another conductive material.
Es kann weiter vorgesehen sein, dass das Handstück der erfindungsgemäßen Elektrode zumindest teilweise als Spritzgussteil und/oder als Schrumpfschlauch ausgebildet ist. Bei einer vorteilhaften Ausgestaltung der erfindungsgemäßen Elektrode kann vorgesehen sein, dass die Elektrode mit zwei oder mehr Körperkontaktelementen ausgestaltet ist, vorzugsweise derart, dass die Körperkontaktelemente in dem einen Handstück integriert und/oder damit fest verbunden sind. Alternativ oder ergänzend zu dieser Ausgestaltung der Erfindung kann vorgesehen sein, dass zwischen dem einen Körperkontaktelement oder den Körperkontaktelementen und dem Handstück jeweils ein Winkel von 90°C eingeschlossen ist, insbesondere zum senkrechten Einführen des Körperkontaktelementes oder der Körperkontaktelemente, in das Gewebe. Alternativ oder ergänzend zu den ergänzenden Merkmalen der breitesten erfindungsgemäßen Ausgestaltung der Elektrode kann vorgesehen sein, dass die Längsachse des Körperkontaktelementes oder die Längsachsen der Körperkontaktelemente koaxial zur Längsachse des Handstücks ausgerichtet ist/sind.It can further be provided that the handpiece of the electrode according to the invention is at least partially designed as an injection molded part and/or as a shrink tube. In an advantageous embodiment of the electrode according to the invention it can be provided that the electrode has two or more body contact elements, preferably in such a way that the body contact elements are integrated into one handpiece and/or firmly connected to it. Alternatively or in addition to this embodiment of the invention, it can be provided that an angle of 90 ° C is included between the one body contact element or elements and the handpiece, in particular for vertical insertion of the body contact element or elements into the tissue. Alternatively or in addition to the additional features of the widest embodiment of the electrode according to the invention, it can be provided that the longitudinal axis of the body contact element or the longitudinal axes of the body contact elements is/are aligned coaxially with the longitudinal axis of the handpiece.
Eine besonders vorteilhafte Ausgestaltung kann vorsehen, dass die erfindungsgemäße Elektrode zwei oder mehr Nadeln aufweist. Vorzugsweise können die Nadeln derart an der Elektrode angeordnet sein, dass die Nadeln mit dem einen Handstück verbunden und/oder in dem einen Handstück, insbesondere in einem Verbindungsbereich des Handstücks, integriert sind.A particularly advantageous embodiment can provide that the electrode according to the invention has two or more needles. Preferably, the needles can be arranged on the electrode in such a way that the needles are connected to one handpiece and/or integrated in one handpiece, in particular in a connection area of the handpiece.
Es kann weiter vorgesehen sein, dass zwischen dem Körperkontaktelement oder den Körperkontaktelementen und dem Handstück, insbesondere der Längsachse des Handstücks, jeweils ein Winkel zwischen 5° und 90°, insbesondere zwischen 45° und 90°, insbesondere von 45° oder von 90°, eingeschlossen ist, vorzugsweise zum senkrechten Einführen der Nadel oder der Nadeln in das Gewebe, oder dass die Längsachse der Nadel oder die Längsachsen der Nadeln koaxial zur Längsachse, insbesondere als Verlängerung des Handstücks, ausgerichtet ist/sind. Eine Ausgestaltung der erfindungsgemäßen Elektrode, bei welcher zwischen der Nadel oder den Nadeln und der Längsachse des Handstücks jeweils ein rechter Winkel eingeschlossen ist, kann den Vorteil haben, dass eine derart ausgestaltete erfindungsgemäße Elektrode, durch senkrecht auf das Handstück ausgeübte Druckausübung, einfach mittels der Nadel oder den Nadeln in ein Gewebe eindrückbar ist.It can further be provided that between the body contact element or elements and the handpiece, in particular the longitudinal axis of the handpiece, there is an angle between 5° and 90°, in particular between 45° and 90°, in particular 45° or 90°, is included, preferably for vertical insertion of the needle or the Needles into the tissue, or that the longitudinal axis of the needle or the longitudinal axes of the needles is/are aligned coaxially to the longitudinal axis, in particular as an extension of the handpiece. An embodiment of the electrode according to the invention, in which a right angle is included between the needle or needles and the longitudinal axis of the handpiece, can have the advantage that an electrode according to the invention designed in this way can be achieved by applying pressure perpendicularly to the handpiece, simply by means of the needle or the needles can be pressed into a tissue.
Es kann vorgesehen sein, dass ein Teil der erfindungsgemäßen Elektrode, insbesondere die zumindest eine Nadel, beschichtet oder unbeschichtet ist und/oder: dass die Elektrode als Korkenzieherelektrode ausgebildet ist, vorzugsweise wobei die zumindest eine Nadel eine Korkenzieherform aufweist. Des Weiteren kann es vorgesehen sein, dass die Elektrode monopolar oder bipolar ausgeführt ist.It can be provided that a part of the electrode according to the invention, in particular the at least one needle, is coated or uncoated and/or: that the electrode is designed as a corkscrew electrode, preferably wherein the at least one needle has a corkscrew shape. Furthermore, it can be provided that the electrode is designed to be monopolar or bipolar.
Aufgrund der zuvor genannten Vorteile der erfindungsgemäßen Elektrode gemäß den hierin beschriebenen und beanspruchten Ausgestaltungen, eignet sich die erfindungsgemäße Elektrode zur Verwendung in Kombination mit einem HF-Chirurgie-Verfahren am Körper eines Lebewesens.Insbesondere eignet sich die erfindungsgemäße Elektrode zur Verwendung zum Verhindern von ungewollten, durch HF-Leckströme induzierte Verbrennungen am Körper eines Lebewesens wie hierin beschrieben.Due to the aforementioned advantages of the electrode according to the invention according to the embodiments described and claimed herein, the electrode according to the invention is suitable for use in combination with an HF surgery method on the body of a living being. In particular, the electrode according to the invention is suitable for use to prevent unwanted, Burns induced by RF leakage currents on the body of a living being as described herein.
"Es kann vorgesehen sein" oder "es kann zweckmäßig sein" oder dergleichen beschreibt jeweils spezielle Ausführungsformen der Erfindung.“It may be provided” or “it may be convenient” or the like each describes specific embodiments of the invention.
Die Erfindung wird::nun anhand mehrerer, illustrierender Ausführungsbeispiele näher beschrieben, ist jedoch nicht auf diese Ausführungsbeispiele beschränkt. Weitere Ausführungsbeispiele ergeben sich durch Kombination einzelner oder mehrerer Merkmale der Schutzansprucheuntereinander und/oder einzelner oder mehreren Merkmale der Ausführungsbeispiele. Solche Ausführungsformen müssen jedoch innerhalb des Schutzbereichs der beigefügten Ansprüche liegen.The invention will now be described in more detail using several illustrative exemplary embodiments, but is not limited to these exemplary embodiments. Further exemplary embodiments result from combining individual or several features of the protection claims with one another and/or individual or several features of the exemplary embodiments. However, such embodiments must be within the scope of the appended claims.
Es zeigt:
- Fig.1
- Ein System mit zwei erfindungsgemäßen Elektroden einer spezifischen Ausführungsform, die mit einem Intraoperativen-Neuromonitoring-Gerät verbunden sind in schematischer Darstellung,
- Fig. 2
- Eine zum Teil als Schnitt durch das Handstück dargestellte, schematische Detailansicht einer in
Fig. 1 abgebildeten und mit einer gestrichelten Linien umrandeten erfindungsgemäßen Elektrode, - Fig. 3
- Eine zum Teil als Schnitt durch das Handstück dargestellte, schematische: Detailansicht einer weiteren bestimmten Ausführungsform einer erfindungsgemäßen Elektrode mit zwei als Nadeln ausgebildeten Körperkontaktelementen,
- Fig. 4
- Eine schematische Detailansicht einer weiteren bestimmten Ausführungsform einer erfindungsgemäßen Elektrode mit zwei als Nadeln ausgebildeten Körperkontaktelementen,
- Fig. 5
- Eine zum Teil als Schnitt durch das Handstück dargestellte, schematische Detailansicht einer weiteren bestimmten Ausführungsform einer erfindungsgemäßen Elektrode mit einem als Schrumpfschlauch ausgebildeten Handstück,
- Fig. 6
- Eine zum Teil als Schnitt durch das Handstück dargestellte, schematische Detailansicht einer weiteren bestimmten Ausführungsform einer erfindungsgemäßen Elektrode mit einem korkenzieherförmigen Körperkontaktelement,
- Fig. 7
- Eine zum Teil als Schnitt durch ein Gehäuse dargestellte, schematische Detailansicht eines nicht erfindungsgemäßen Nachrüstelements in Draufsicht,
- Fig. 8
- Eine schematische Darstellung eines unteren Teils eines Gehäuses eines nicht erfindungsgemäßen Nachrüstelements in perspektivischer Ansicht,
- Fig. 9
- Eine zum Teil transparent und schematisch dargestellte, perspektivische Ansicht eines nicht erfindungsgemäßen Nachrüstelements,
- Fig. 10
- Eine schematische Darstellung einesvorbekannten Systems (entsprichtdem Stand der Technik).
- Fig.1
- A system with two electrodes according to the invention of a specific embodiment, which are connected to an intraoperative neuromonitoring device in a schematic representation,
- Fig. 2
- A schematic detailed view, partly shown as a section through the handpiece
Fig. 1 electrode according to the invention shown and surrounded by dashed lines, - Fig. 3
- A schematic detailed view of a further specific embodiment, partially shown as a section through the handpiece Electrode according to the invention with two body contact elements designed as needles,
- Fig. 4
- A schematic detailed view of a further specific embodiment of an electrode according to the invention with two body contact elements designed as needles,
- Fig. 5
- A schematic detailed view, partly shown as a section through the handpiece, of a further specific embodiment of an electrode according to the invention with a handpiece designed as a shrink tube,
- Fig. 6
- A schematic detailed view, partly shown as a section through the handpiece, of a further specific embodiment of an electrode according to the invention with a corkscrew-shaped body contact element,
- Fig. 7
- A schematic detailed view of a retrofit element not according to the invention in plan view, partly shown as a section through a housing,
- Fig. 8
- A schematic representation of a lower part of a housing of a retrofit element not according to the invention in a perspective view,
- Fig. 9
- A partially transparent and schematically illustrated perspective view of a retrofit element not according to the invention,
- Fig. 10
- A schematic representation of a previously known system (corresponding to the prior art).
In
In
Zur einfacheren Handhabung der erfindungsgemäßen Elektrode 1, 2, 3, 4, 30 ist allgemein vorgesehen, dass diese ein mit dem Körperkontaktelement 5 verbundenes Handstück 6, geeignet zum Greifen der Elektrode 1, 2, 3, 4, 30 aufweist. Um das Abfließen von HF-Leckströmen über die erfindungsgemäße Elektrode 1, 2, 3, 4, 30 bei einer Verwendung der Elektrode 1, 2, 3, 4, 30 in Kombination mit einem HF-Chirurgie-Verfahren zu verhindern, ist vorgesehen, dass die Elektrode 1, 2, 3, 4, 30 eine Drossel 7 aufweist. Erfindungsgemäß ist die Drossel 7, wie in den
Die Stromleitung 8 zum Anschließen der erfindungsgemäßen Elektrode 1 kann als fester Bestandteil der erfindungsgemäßen Elektrode 1, 2, 3, 4, 30, insbesondere am Handstück 6 befestigt, ausgestaltet sein oder mit dem Handstück 6 über ein oder mehrere Kontaktelemente (nicht dargestellt), insbesondere über einen Stecker und eine Buchse, verbindbar sein, insbesondere derart, dass die Stromleitung 8 lösbar mit dem Handstück 6 verbindbar ist. Vorzugsweise ist die Stromleitung 8 als nach außen hin isolierte Kabelleitung ausgebildet. Vorzugsweise beträgt die Gesamtlänge der Stromleitung 8 der Elektrode, insbesondere der Stromleitung zwischen Elektrode und IOM-Gerät oder zwischen Elektrode und einer Adapterbox,zwischen 0,10m und 7,0 m, insbesondere zwischen 0,25 m und 5,0 m, insbesondere zwischen 0,5 und 4,5 m, insbesondere zwischen 0,8 m und 4,0 m, insbesondere zwischen 1,0 und 3,5 m, vorzugsweise zwischen 0,12 m und 3,0 m, vorzugsweise zwischen 1,2 m und 1,5 m.The
Die Drossel 7 kann eine Induktivität zwischen 1,0 µH und 100,0 mH, insbesondere zwischen 100,0 µH und 20,0 mH, insbesondere zwischen 1,0 mH und 10,0 mH, insbesondere, zwischen 2,0 mH und 9,0 mH, insbesondere zwischen 3,0 mH und 8,0 mH, insbesondere zwischen 4,0 mH und 7,0 mH, vorzugsweise von 4,7 mH oder 6,8 mH aufweisen. Vorzugsweise ist die Drossel 7 der erfindungsgemäßen Elektrode 1, 2, 3, 4, 30 dadurch derart eingerichtet, dass ein Bandbreitenfilter zur Erzeugung einer Resonanzfrequenz von höchstens 400 kHz, insbesondere von höchstens 300 kHz, insbesondere von höchstens 250 kHz, insbesondere höchstens 220 kHz, erzeugbar ist oder entsteht.The
Das Körperkontaktelement 5, welches, wie hier in den
Das Handstück 6 kann zum Beispiel als ein Gehäuse ausgestaltet sein, welches beispielsweise aus Kunststoff hergestellt ist. Es kann insbesondere vorteilhaft sein, wenn zumindest ein Teil des Handstücks 6 als Spritzgussteil 10 und/oder als Schrumpfschlauch 11 (siehe
In den
Bei der in
Bei der in
In
Bei der in
Um die wesentlichen Unterschiede der erfindungsgemäßen Elektrode 1, 2, 3, 4, 30 gegenüber konventionellen Elektroden beziehungsweise eines Systems 100 mit einer erfindungsgemäßen Elektrode 1, 2, 3, 4, 30 (in
In den
So kann beispielweise vorgesehen sein, dass ein Gehäuse 18 ein erstes Gehäuseteil 25 und ein zweites Gehäuseteil 26 aufweist, wobei es derart ausgestaltet ist, dass es von einer Offenstellung, in welcher eine durchgehende (=nicht unterbrochene) Stromleitung 8 in das Nachrüstelement 20 einsetzbar ist, in eine Schließstellung durch Zusammenfügen des ersten Gehäuseteils 25 mit dem zweiten Gehäuseteil 26 versetzbar ist.For example, it can be provided that a
Damit das Nachrüstelement 20 möglichst einfach in eine durchgehende Stromleitung 8 einsetzbar ist, kann vorgesehen sein, dass es eine Schneidevorrichtung 22, insbesondere eine zumindest teilweise leitfähige Schneidevorrichtung 22, zum Durchtrennen und/oder zum Entfernen eines Teils der Stromleitung 8 aufweist, wobei durch die Schneidevorrichtung 22 zwei freie Enden 23 der Stromleitung 8 erzeugbar sind, an welche wiederum die beiden Kontaktelemente 21 ansetzen, um das Nachrüstelement 20 als Leitungszwischenstück mit der Stromleitung 8 zu verbinden. Die Kontaktelemente 21 und die Schneidevorrichtung 22 können, wie in den
Besonders vorteilhaft kann es sein, wenn das Nachrüstelement 20 als Nachrüst-Clip ausgestaltet ist, wobei die beiden Gehäuseteile 25, 26 mittels zumindest eines Scharniers relativ zueinander beweglich verbunden sein können, so dass das Nachrüstelement 20 mittels des zumindest einen Scharniers öffenbar und schließbar ist oder mittels eines Clip-Mechanismus verbindbar sind oder miteinander verbunden sind, wobei das Nachrüstelement 20 durch Zusammenclippen der beiden Gehäuseteile 25, 26 in eine Schließstellung, insbesondere reversibel, versetzbar ist. Hierbei kann es beispielsweise vorgesehen sein, dass das als Nachrüst-Clip ausgestaltete Nachrüstelement 20 eine kombinierte Schneide-Kontakt-Vorrichtung (wobei diese derart ausgestaltet sein kann, wie bereits zuvor beschrieben wurde) zum Durchtrennen und Entfernen eines abgetrennten Teils 28 der Stromleitung 8 und zum gleichzeitigen Anschließen von zwei freien Enden 23 der unterbrochenen Stromleitung aufweist.It can be particularly advantageous if the
In Schließstellung des Nachrüstelements 20 ist vorgesehen, dass ein Stromfluss lediglich durch die Drossel 7 des Nachrüstelements 20 möglich ist. Um dies zu verwirklichen, kann beispielsweise vorgesehen sein, dass durch eine beim Schließen der beiden Gehäuseteile 25, 26 erzeugte Betätigungskraft eine Schneidevorrichtung 22 betätigbar ist, wodurch die Stromleitung::8 mittels der Schneidevorrichtung 22 an zumindest einer Stelle durchtrennbar ist und somit zumindest zwei freie Enden 23 der Stromleitung 8 erzeugbar sind. Es kann ebenso vorgesehen sein, dass durch die Schneidevorrichtung 22 ein Zwischenstück oder ein Teil 28 der Stromleitung 8 herausgeschnitten wird. Somit entstehen drei Leitungsteile: ein Teil der Stromleitung 8 zum Körperkontaktelement 5, ein Teil der Stromleitung 8 zum IOM-Gerät 9 und/oder zum Verbindungselement 16 sowie das abgetrennte Leitungsstück 28, welches insbesondere in einer Wanne, insbesondere einer Kunststoffwanne, aufnehmbar ist oder durch eine Öffnung, welche als Auswurf dient, auswerfbar ist, so dass kein Strom mehr über das abgetrennte Leitungsstück 28 fließen kann. Durch zumindest zwei Klemmvorrichtungen 27, die vorzugsweise am Gehäuse 18 ausgestaltet sind, welche in Schließstellung des Gehäuses 18 den Teil der Stromleitung 8 zum Körperkontaktelement 5 und den Teil der Stromleitung 8 zum IOM-System greifen, werden die freien Enden 23 der Stromleitung 8 in dem Nachrüstelement: 20 fixiert. Die Klemmvorrichtungen 27 können beispielsweise als Durchlassöffnungen, vorzugsweise als runde oder ovale Durchlassöffnungen, am Gehäuse 18 ausgebildet sein. In Schließstellung des Nachrüstelements 20 verbinden die beiden Kontaktelemente 21 die Drossel 7 als Leitungszwischenstück der Stromleitung 8 mit den beiden freien Enden 23. Insbesondere kann vorgesehen sein, dass der Strom dann nur noch über die Abscherbleche und somit über die Drossel 7 fließt.In the closed position of the
- 11
- Ausführungsform der erfindungsgemäßen ElektrodeEmbodiment of the electrode according to the invention
- 22
- Ausführungsform der erfindungsgemäßen ElektrodeEmbodiment of the electrode according to the invention
- 33
- Ausführungsform der erfindungsgemäßen ElektrodeEmbodiment of the electrode according to the invention
- 44
- Ausführungsform der erfindungsgemäßen ElektrodeEmbodiment of the electrode according to the invention
- 3030
- Ausführungsform der erfindungsgemäßen ElektrodeEmbodiment of the electrode according to the invention
- 55
- KörperkontraktelementBody contract element
- 66
- HandstückHandpiece
- 77
- Drosselthrottle
- 88th
- Stromleitung der ElektrodeElectrode power line
- 99
- Intraoperatives-Neuromonitoring-GerätIntraoperative neuromonitoring device
- 1010
- SpritzgussteilInjection molded part
- 1111
- SchrumpfschlauchHeat shrink tubing
- 1212
- Gewebetissue
- 1313
-
Längsachse des Handstücks 6Longitudinal axis of the
handpiece 6 - 1414
-
Längsachse des Körperkontaktelements 5Longitudinal axis of the
body contact element 5 - 1515
- GriffflächeGrip surface
- 1616
- Verbindungselementconnecting element
- 1717
-
Stromleitung vom Verbindungselement 16 zum intraoperativen-Neuromonitoring-Gerät 9Power line from the connecting
element 16 to theintraoperative neuromonitoring device 9 - 1818
- GehäuseHousing
- 19:19:
- konventionelle Elektrode (Stand der Technik)conventional electrode (state of the art)
- 2020
- NachrüstelementRetrofit element
- 2121
- KontaktelementContact element
- 2222
- Schneidevorrichtungcutting device
- 2323
-
freie Enden der Stromleitung 8free ends of the
power line 8 - 2424
- Crimp-AnschlussCrimp connection
- 2525
- erstes Gehäuseteilfirst housing part
- 2626
- zweites Gehäuseteilsecond housing part
- 2727
- KlemmvorrichtungClamping device
- 2828
- Abgetrenntes LeitungsstückSeparated piece of pipe
- 100100
- Systemsystem
Claims (7)
- Electrode (1, 2, 3, 4, 30) designed for use on the body of a living being, comprising a body contact element (5) for bringing the electrode (1, 2, 3, 4, 30) to lie against a tissue (12), comprising a handpiece (6) for gripping the electrode (1, 2, 3, 4, 30), which handpiece is connected to the body contact element (5), and comprising a throttle (7) in the form of one or more coils for preventing the outflow of HF leakage currents through the electrode (1, 2, 3, 4, 30) when the electrode (1) is being used in combination with a HF surgical procedure, wherein the body contact element (5) is in the form of an electrically conductive needle for insertion, in particular for subdermal puncture, into the tissue (12) and in that the throttle (7) is integrated in the handpiece (6).
- Electrode (1, 2, 3, 4, 30) according to Claim 1, characterized in that the throttle (7) has an inductance between 1.0 µH and 100.0 mH, in particular between 100.0 µH and 20.0 mH, in particular between 1.0 mH and 10.0 mH, in particular between 2.0 mH and 9.0 mH, in particular between 3.0 mH and 8.0 mH, in particular between 4.0 mH and 7.0 mH, preferably 4.7 mH or 6.8 mH, and/or in that the throttle (7) is designed such that a bandwidth filter for generating a resonant frequency of at most 400 kHz, in particular at most 300 kHz, in particular at most 250 kHz, in particular at most 220 kHz, can be created or is produced.
- Electrode (1, 2, 3, 4, 30) according to either of Claims 1 and 2, characterized in that the electrode (1, 2, 3, 4, 30) is designed for use with an intraoperative neuromonitoring apparatus (9) for controlling the stimulability of functions controlled by the somatic and/or autonomic nervous system, in particular for generating neurophysiological signals and/or for stimulating functions controlled by the autonomic nervous system, preferably in surgical use in orthopaedics, ENT, neurosurgery and/or general surgery.
- Electrode (1, 2, 3, 4, 30) according to one of Claims 1 to 3, characterized in that the body contact element (5) is at least partially conductive, preferably is produced from metal, in particular from stainless steel, platinum-iridium or other metals, and/or in that the body contact element (5) has a length between 3.0 mm and 60.0 mm and/or an outside diameter between 0.1 mm and 8.0 mm.
- Electrode (1, 2, 3, 4, 30) according to one of Claims 1 to 4, characterized in that the handpiece (6) is at least partially in the form of an injection moulded part (10) and/or a shrink tube (11).
- Electrode (1, 2, 3, 4, 30) according to one of Claims 1 to 5, characterized in that the electrode (1, 2, 3, 4, 30) is formed with two or more body contact elements (5) such that the body contact elements (5) are connected to the one handpiece (6), and/or in that an angle of approximately 90° is formed between each body contact element (5) and the handpiece (6), in particular for the perpendicular insertion of the body contact element (5) into the tissue, or in that the longitudinal axes (14) of the body contact elements (5) are aligned coaxially with the longitudinal axis (13) of the handpiece.
- Electrode (1, 2, 3, 4, 30) according to one of Claims 1 to 6, characterized in that the needle or the needles is/are coated or uncoated and/or in that the electrode is in the form of a corkscrew electrode, preferably wherein the needle has a corkscrew shape, preferably wherein the electrode (1, 2, 3, 4, 30) has a monopolar or bipolar design.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP15003024.5A EP3158960B1 (en) | 2015-10-22 | 2015-10-22 | Electrode with a throttle for preventing burns induced by hf leak currents |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP15003024.5A EP3158960B1 (en) | 2015-10-22 | 2015-10-22 | Electrode with a throttle for preventing burns induced by hf leak currents |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EP3158960A1 EP3158960A1 (en) | 2017-04-26 |
| EP3158960B1 true EP3158960B1 (en) | 2023-10-18 |
Family
ID=54360845
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP15003024.5A Active EP3158960B1 (en) | 2015-10-22 | 2015-10-22 | Electrode with a throttle for preventing burns induced by hf leak currents |
Country Status (1)
| Country | Link |
|---|---|
| EP (1) | EP3158960B1 (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE102019216119B4 (en) * | 2019-10-18 | 2024-06-06 | Inomed Medizintechnik Gmbh | Bipolar mapping suction cup |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0057213B1 (en) * | 1980-08-08 | 1989-11-15 | R2 Corporation | Arrangement for connecting an electrode set to various instruments |
| EP2314244A1 (en) * | 1994-12-13 | 2011-04-27 | Torben Lorentzen | An electrosurgical instrument for tissue ablation, an apparatus, and a method for providing a lesion in damaged and diseased tissue from a mammal |
| EP2597481A1 (en) * | 2011-11-22 | 2013-05-29 | Koninklijke Philips Electronics N.V. | RF-safe interventional or non-interventional instrument for use in an MRI apparatus |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4945912A (en) * | 1988-11-25 | 1990-08-07 | Sensor Electronics, Inc. | Catheter with radiofrequency heating applicator |
| FR2704131B1 (en) * | 1993-04-22 | 1995-06-30 | Odam | Sensor device for electrocardiogram. |
| US6246902B1 (en) * | 1999-05-04 | 2001-06-12 | Siemens Medical Systems, Inc. | Lead set filter for a patient monitor |
| DE102004037375A1 (en) * | 2004-08-02 | 2006-03-30 | Siemens Ag | Physiological sensor system |
| AU2008236665B2 (en) * | 2007-04-03 | 2013-08-22 | Nuvasive, Inc. | Neurophysiologic monitoring system |
| US8882763B2 (en) * | 2010-01-12 | 2014-11-11 | Greatbatch Ltd. | Patient attached bonding strap for energy dissipation from a probe or a catheter during magnetic resonance imaging |
-
2015
- 2015-10-22 EP EP15003024.5A patent/EP3158960B1/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0057213B1 (en) * | 1980-08-08 | 1989-11-15 | R2 Corporation | Arrangement for connecting an electrode set to various instruments |
| EP2314244A1 (en) * | 1994-12-13 | 2011-04-27 | Torben Lorentzen | An electrosurgical instrument for tissue ablation, an apparatus, and a method for providing a lesion in damaged and diseased tissue from a mammal |
| EP2597481A1 (en) * | 2011-11-22 | 2013-05-29 | Koninklijke Philips Electronics N.V. | RF-safe interventional or non-interventional instrument for use in an MRI apparatus |
Also Published As
| Publication number | Publication date |
|---|---|
| EP3158960A1 (en) | 2017-04-26 |
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